BOLSTER: Learning New Skills to Thrive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient
Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)
Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)
Disqualifiers
Has cognitive impairments (as determined by the patient's oncologist)
Planning to enroll in hospice
Unable to complete baseline survey
Adults unable to consent
Trial design
Design model
Parallel
Treatments tested in this trial
BOLSTER Program
BehavioralThis supportive care program includes six telehealth sessions led by a trained nurse to help patients with advanced gynecological or gastrointestinal cancers and their care partners build skills, manage symptoms, and cope with challenges. Two additional sessions will be help support care partners. Participants will also get access to the BOLSTER website, which offers personalized educational materials to support their well-being
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Usual CareNo intervention 0 interventions
Group B: Arm 2: Bolster ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Time frame
Baseline to 6 weeks post-discharge2
Change in FACT-G Score From Baseline to Week 6 (Arm 2)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Time frame
Baseline to 6 weeks post-dischargeSecondary outcomes
1
Change in FACT-G Score From Baseline to Week 12 (Arm 1)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Time frame
Baseline to 12 weeks post-discharge2
Change in FACT-G Score From Baseline to Week 12 (Arm 2)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Time frame
Baseline to 12 weeks post-discharge3
Change in Functional Assessment of Cancer Therapy-General 7 item Version (FACT-G7) Score from Baseline to Week 6 (Arm 1)
Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 28. A higher score indicates better quality of life.
Time frame
Baseline to 6 weeks post-discharge4
Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)
Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 28. A higher score indicates better quality of life.
Time frame
Baseline to 6 weeks post-dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov